MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX

Model Number 866389

Device Problem Defective Alarm (1014)

Patient Problems Asystole (4442); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2023

Event Type  Death  

Manufacturer Narrative

Philips is in process of obtaining additional information.A final report will be submitted upon completion of the investigation.

Event Description

The customer reported that a patient was found dead.The monitor did not detect the asystole and there was no alert via central monitoring from the monitor at the bedside location.

Manufacturer Narrative

A philips remote service engineer (rse) confirmed an adverse event informed by the chief physician of the intensive care unit; that on october 26th around 7:30 p.M.An isolated patient with covid pneumonia (with a fixed therapy limitation without intubation/resuscitation) was found deceased in the intensive care unit.It was reported that the monitor did not detect the asystole and that there was no alarm message via the central monitoring from the monitor at the bedside.The patient was an 85-year-old male, and the cause of death remains unknown to philips.A philips field service engineer (fse) visited the customer site to evaluate the alleged malfunctioning devices, collect logs, and clinical audit trails.Results of functional tests, mtk (metrological controls), stk (safety control checks) and metrological inspection, confirmed that both x3 and mx-750 devices were working per specification.Furthermore, the fse confirmed that electrocardiogram (ecg) from alarm has been reconfigured from blue technical alarm to yellow alarm and the alarm source has been changed from ecg to "auto".The complaint was escalated for technical investigation.A philips product support engineer (pse) and a philips clinical specialist (cs) evaluated the following documents: workflow, audit log (entire ¿ unfiltered ¿ unit ¿ seven days of data), configuration file for host and companion monitors, device log from host/companion/mms monitors, alarm review from pic ix and ivpm, rhythm strips and technical logs.The monitor is set for split latching.When the x3 (set for red/yellow latching) is connected to the monitor that the monitor determines the alarm settings.Based on the information available and the testing conducted confirming that alarm for arrhythmia was off, respiratory alarms were off, spo2 limits were wide and that the electrocardiogram (ecg) leads were noted to be off as well.In addition, it was indicated that the asystole was not detected because one or more leads were off, though the monitor provided an inop alarm for ecg off, users did not respond to the inop and due to the lack of alarm, there was a delay in care to the patient.Due to aforementioned information, it appears the device function did not cause or contribute to the reported event; however, alarm management or user response to inops may have been a factor.The reported problem was not confirmed.Philips tested the devices, evaluated audit logs, and configuration file; and no malfunction of the monitors was confirmed.Philips determined that asystole was not detected because one or more leads were off, though the monitor provided an inop alarm for ecg off.Users did not respond to the inop and due to the lack of alarm, there was a delay in care for the patient.The device function did not cause or contribute to the reported event; however, alarm management or user response to inops may have been a factor.The device remains at the customer site.The investigation concludes that no further action is required at this time.Corrected: serial # (d4).

Event Description

Philips received a complaint on the (pic) patient information center ix, indicating, indicating the monitor did not recognize the asystole and there was no alarm message via the central monitoring".The patient died.The device was in clinical use at the time of the event.

Manufacturer Narrative

A philips remote service engineer (rse) confirmed an adverse event informed by the chief physician of the intensive care unit; that on october 26th around 7:30 p.M.An isolated patient with covid pneumonia (with a fixed therapy limitation without intubation/resuscitation) was found deceased in the intensive care unit.It was reported that the monitor did not detect the asystole and that there was no alarm message via the central monitoring from the monitor at the bedside.The patient was an 85-year-old male, and the cause of death remains unknown to philips.A philips field service engineer (fse) visited the customer site to evaluate the alleged malfunctioning devices, collect logs, and clinical audit trails.Results of functional tests, mtk (metrological controls), stk (safety control checks) and metrological inspection, confirmed that both x3 and mx-750 devices were working per specification.Furthermore, the fse confirmed that electrocardiogram (ecg) from alarm has been reconfigured from blue technical alarm to yellow alarm and the alarm source has been changed from ecg to "auto".The complaint was escalated for technical investigation.A philips product support engineer (pse) and a philips clinical specialist (cs) evaluated the following documents: workflow, audit log (entire ¿ unfiltered ¿ unit ¿ seven days of data), configuration file for host and companion monitors, device log from host/companion/mms monitors, alarm review from pic ix and ivpm, rhythm strips and technical logs.The monitor is set for split latching.When the x3 (set for red/yellow latching) is connected to the monitor that the monitor determines the alarm settings.Based on the information available and the testing conducted confirming that alarm for arrhythmia was off, respiratory alarms were off, spo2 limits were wide and that the electrocardiogram (ecg) leads were noted to be off as well.In addition, it was indicated that the asystole was not detected because one or more leads were off, though the monitor provided an inop alarm for ecg off, users did not respond to the inop and due to the lack of alarm, there was a delay in care to the patient.Due to aforementioned information, it appears the device function did not cause or contribute to the reported event; however, alarm management or user response to inops may have been a factor.The reported problem was not confirmed.Philips tested the devices, evaluated audit logs, and configuration file; and no malfunction of the monitors was confirmed.Philips determined that asystole was not detected because one or more leads were off, though the monitor provided an inop alarm for ecg off.Users did not respond to the inop and due to the lack of alarm, there was a delay in care for the patient.The device function did not cause or contribute to the reported event; however, alarm management or user response to inops may have been a factor.The device remains at the customer site.The investigation concludes that no further action is required at this time.Corrected: serial # (d4).

Event Description

Philips received a complaint on the (pic) patient information center ix, indicating, indicating the monitor did not recognize the asystole and there was no alarm message via the central monitoring".The patient died.The device was in clinical use at the time of the event.

• Brand Name: PATIENT INFORMATION CENTER IX
• Type of Device: PATIENT INFORMATION CENTER IX
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: hisham alzayat ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 18096870
• MDR Text Key: 327678911
• Report Number: 1218950-2023-00847
• Device Sequence Number: 1
• Product Code: MHX
• UDI-Device Identifier: 00884838048645
• UDI-Public: 00884838048645
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153702
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 866389
• Device Catalogue Number: 866389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/08/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 01/03/2024
• Supplement Dates FDA Received: 01/22/2024; 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 88 KG